Ibrutinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of ibrutinib.

Keywords: Bioequivalence, generics, ibrutinib

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current version - effective from 01/01/2023

Ibrutinib hard capsules 140 mg and film-coated tablets 140, 280, 420 & 560 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/371445/2021 Legal effective date: 01/01/2023

Document history

Ibrutinib hard capsules 140 mg and film-coated tablets 140, 280, 420 & 560 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/371445/2021 Legal effective date: 01/01/2023

Draft ibrutinib hard capsules 140 mg and film-coated tablets 140, 280, 420 & 560 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 16/12/2021 to 31/03/2022 Reference Number: EMA/CHMP/371445/2021 Summary:

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